AstraZeneca ((AZN)), Icon Plc ((ICLR)) announced an update on their ongoing clinical study.
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AstraZeneca and Icon Plc have launched a new clinical study titled ‘The Eplontersen Pregnancy and Lactation Outcomes Study (EPPRO).’ This observational study aims to assess the safety of eplontersen exposure during pregnancy and lactation, focusing on potential complications for both mothers and their offspring. The study is significant as it addresses safety concerns for pregnant and lactating individuals with Transthyretin Amyloidosis.
The intervention being tested is eplontersen, a treatment intended to manage Transthyretin Amyloidosis. This study will observe its effects on pregnant and lactating individuals, providing crucial safety data.
Designed as a prospective, case-only observational study, EPPRO will not involve random allocation or masking. Its primary purpose is to gather descriptive safety data on eplontersen exposure during critical reproductive periods.
The study is set to begin on September 17, 2025, with its primary completion date yet to be determined. The latest update was submitted on October 2, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
The initiation of this study could positively influence AstraZeneca’s and Icon Plc’s stock performance by demonstrating their commitment to comprehensive drug safety research. It may also affect investor sentiment positively, given the growing focus on maternal health in the pharmaceutical industry.
The Eplontersen Pregnancy and Lactation Outcomes Study is ongoing, with further details available on the ClinicalTrials portal.